The European Medicines Agency (EMA) has given the green light to the first Alzheimer’s therapy in the EU that focuses on the underlying disease processes. The agency recommended approval of the antibody lecanemab for the treatment of mild cognitive impairment (memory and thinking problems) or mild dementia in the early stages of Alzheimer’s disease.
However, there is one limitation: the recommendation is that the drug should only be approved for Alzheimer’s patients who have only one or no copy of ApoE4, a specific form of the gene for the apolipoprotein E protein.
They are less likely to have certain serious side effects – swelling and bleeding in the brain – than people with two copies of ApoE4. Other Alzheimer’s therapies only treat the symptoms of the disease.
Second check after rejection
The EU Commission responsible for approval usually follows the authority’s vote. The manufacturers of Lecanemab are the pharmaceutical companies Eisai (Japan) and Biogen (USA). In July, the EU Medicines Agency rejected approval: the risk of serious side effects from the antibody would be greater than the expected positive effect. The drug’s manufacturer had requested a second review.
Protein fragment is removed from the brain
The antibody, which has been approved in the US since early 2023 under the trade name Leqembi, is intended to remove the protein fragment beta-amyloid (Aß) from the brain. “Amyloid β is probably at the beginning of a cascade of neuronal pathological changes in the brain,” says Jörg Schulz from Aachen University Hospital, spokesperson for the “Dementia and Cognitive Disorders” committee of the German Society of Neurology (DGN).
Source: Krone
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